Darzalex® (daratumumab)

DARZALEX®(daratumumab) is a human CD38-directed monoclonal antibody indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.

For more information about Darzalex, please visit their website www.darzalex.com

Approved for patients who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent

Antibody administration:

•Risk of a temporary infusion reaction with first dose, but most are mild following premedication with dexamethasone, acetaminophen
•Requires post-medication with oral steroid for 2 days to prevent late reactions.
•Initially infused at a slow rate and then escalated over time
•Schedule: Weekly x 8, then every 2 weeks x 8 , then every 4 weeks

Pearls for patients:

•Can cause interference with tests for blood cell type matching
•Take as long as it is working and if side effects are manageable

General Information

DARZALEX™ is a human CD38-directed monoclonal antibody indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.

Janssen CarePath is a comprehensive support system to help patients start and stay on therapy. Janssen CarePath Case Coordinators can offer you and your patients access support and educational resources related to DARZALEX™ (daratumumab).

This booklet addresses a highly effective new medication to treat myeloma, a laboratory-made monoclonal antibody that targets a specific single protein on the surface of myeloma cells. Of the four new therapies for myeloma approved in 2015 by the FDA, only Darzalex has single-agent activity and was approved with “breakthrough” status.

Possible Side Effects

Infusion reactions

Infusion reactions can occur with many intravenously-administered cancer therapies. Infusion reactions to monoclonal antibodies are caused by the release of cytokines, and are sometimes referred to as “cytokine-release syndrome.” Cytokines are small proteins that are released by cells in order to affect the behavior of other cells. Infusion reactions result from the release of cytokines from cells targeted by the monoclonal antibody as well as from immune system cells that are recruited to the targeted area. Reactions are often flu-like in nature, and include nasal congestion, fever, chills, cough, throat irritation, difficulty breathing, low blood pressure, nausea, and rash.

Infusion reactions occurred in 46% of the patients in the registration trials for Darzalex, most of them mild to moder-ate, and most occurring during or within four hours after the first infusion. Infusion reactions occurred in 5% of the patients with the second infusion, and in 4% with subsequent infusions. Infusion reactions that were severe enough to require hos-pitalization occurred in 3% of patients. There were no life-threatening infusion reactions.

Fatigue

Fatigue is commonly associated with cancer and with cancer therapy. 39% of the patients in the registration trials for Darzalex experienced fatigue, all but 2% of which was mild to moderate and did not limit the patients’ ability to care for themselves. Caution is advised if you are operating machinery, including auto-mobiles. For more detailed information, please see the IMF publicationUnderstanding Fatigue.

Back pain

Treatment-related (rather than myeloma-related) back pain can occur as a result of inflammatory cytokines released in reaction to the monoclonal antibody, or may occur because a patient receiving Darzalex has low levels of white blood cells and develops an infection with con-comitant body aches and pains. Of the 25% of patients who experienced back pain in the Darzalex registration trials, only 2% experienced back pain that was severe enough to limit their ability to care for themselves.

Nausea

Approximately one quarter of the patients in the registration trials had mild to moderate nausea. There were no cases of severe nausea.

Fever

Fever is defined as an oral temperature greater than 38°C or 100.4°F. When the white blood cell count is low, the body’s ability to defend itself against infections is compromised, and fever needs to be further evaluated immediately. Fever can also be a sign of the interaction of the monoclonal antibody with the immune

Cough

Infusion reactions to Darzalex have included a range of respiratory symptoms such as cough, wheezing, throat tightness and irritation, swelling of the throat and lungs, nasal congestion, and allergic rhinitis (irritation and inflammation of the mucus membranes inside the nose). Cough was reported in 21% of the patients enrolled in the registration trials for Darzalex, all of it mild to moderate.

Upper respiratory tract infection (URI)

Upper respiratory tract infection is a bacterial or viral infection of the nose, throat, sinuses, or larynx. 20% of the patients in the registration trials for Darzalex had a URI; all but 1% were mild to moderate.

Clinical Trials

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.